FDA Adverse Event
Other
Summary report: N
PREMIER
MDR report key: 1691563
·
Received May 14, 2010
Report
- Report Number
- 2511556-2010-00003
- Event Type
- Other
- Date Received
- May 14, 2010
- Date of Event
- April 21, 2010
- Report Date
- April 21, 2010
- Manufacturer
- PREMIER DENTAL PRODUCTS CO.
- Product Code
- DYH
- PMA / PMN Number
- K083695
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
DENTIST WAS WORKING ON TOOTH #31 AND NUMBED THE PATIENT WITH POLOCAINE BEFORE BEGINNING THE PROCEDURE. THE PATIENT'S FACE INSTANTLY SWELLED AFTER ADMINISTERING THE TRAXODENT RETRACTION MATERIAL. PATIENT HAD AN ALLERGIC REACTION AND WAS SENT TO THE EMERGENCY ROOM WHERE SHE WAS GIVEN BENADRYL IV. ON (B)(6) 2010, THE OFFICE REPORTED THE PATIENT WAS STILL SORE AND SWOLLEN BUT DOING MUCH BETTER THAN THE DAY BEFORE. THE OFFICE HAS USED TRAXODENT ON OTHER PATIENTS WITHOUT ANY PROBLEMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PREMIER | RETRACTION PASTE | DYH | PREMIER DENTAL PRODUCTS CO. | 5813 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |